Drug Safety: Withdrawals & Recalls

On March 7, 2014, the United States Food and Drug Administration (FDA) issued a voluntary recall of Effexor® XR (venlafaxine HCl) 150 mg extended-release capsules

This recall was issued because of a report that one bottle of Effexor XR (venlafaxine HCl) 150 mg extended-release capsules contained one Tikosyn® 0.25mg capsule. While there is a very low probability that other bottles of Effexor XR (venlafaxine HCl) 150 mg extended-release capsules contain a Tikosyn capsule, Pfizer has initiated this voluntary recall as a precaution.

 This recall affects the following products and lot numbers:

Drug Name NDC Affected Lots
Effexor XR 150mg capsules 00008-0836-22 V130140 exp 10/15
Effexor XR 150mg capsules 00008-0836-21 V130142 exp 10/15
Venlafaxine ER 150mg capsules 59762-0182-02 V130014 exp 08/15

 If you received your Effexor XR (venlafaxine HCl) in the original manufacturer’s bottle, please check the lot number. The lot number can be found on the right hand side of the manufacturer’s label underneath the barcode. If your product is not from one of these affected lots, it is not affected by this recall. If your product is from one of these affected lots, please return it to the pharmacy that filled your prescription.

Effexor XR (venlafaxine HCl) are dark orange-colored imprinted with W and “Effexor XR 150”. Tikosyn 0.25mg capsules are peach-colored imprinted with “Pfizer TKN 250”. Please check and make sure you do not have any peach-colored capsules imprinted with “Pfizer TKN 250” mixed in with your medicine. If you do not, you are not affected by this recall. If you do, please return it to the pharmacy that filled your prescription.

Where to call if you have questions

If you are using product that is affected by this recall, talk to your doctor. He or she is familiar with your medical history and can:

  • Suggest the best treatment option for you
  • Write you a prescription for a different medicine, if appropriate
Please call if you have any questions
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